Clemastine Fumarate

Product NDC
54838-514
11-digit product format
548380514
Labeler code
54838
Product ID
54838-514_00a84afa-9348-4cd4-8151-2afab977ea09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clemastine Fumarate
Dosage form
SYRUP
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA074884
Marketing category
ANDA
Marketing start
1997-12-17
Marketing end
0000-00-00
Substance
CLEMASTINE FUMARATE
Active strength
1 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-514-4054838051440120 mL in 1 BOTTLE, PLASTIC (54838-514-40) 120 ml1997-12-170000-00-00NoNoCurrent
54838-514-8054838051480473 mL in 1 BOTTLE, PLASTIC (54838-514-80) 473 ml1997-12-170000-00-00NoNoCurrent